Capsule dispensing container

ABSTRACT

A package for delivering a single-dose product includes a softgel capsule which is comprised of at least one gelling agent selected from protein-based gelling agents and polysaccharide-based gelling agents. The capsule shell includes one or more areas of reduced thickness that are preferentially ruptured by exertion of a compressive force on the softgel capsule to create an opening in the capsule shell through which the fill composition can be delivered by spraying or squeezing. A method for manufacturing the softgel capsule having one or more areas of reduced shell thickness is also described.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to single-dose capsules. In particular,the invention is directed to softgel capsules with at least one area ofreduced thickness for delivering the content in the softgel capsule as asingle-dose by squeezing and/or as a spray.

2. Description of the Related Technology

In the field of perfumery and cosmetics, it is common practice todistribute to the public free samples which contain a single-dose of theproduct in order to offer a chance to try the product. In addition,nutritional supplements or pharmaceutical agents in liquid carriers arealso often distributed in single-dose containers. These single-doseforms have many advantages over other dosage forms such as bulk liquidpreparations. For example, the content in a single-dose form can beindividually fully identifiable and the integrity of the dosage form isprotected until the actual moment of administration. If the content,e.g. cosmetics, nutritional supplements, pharmaceuticals, etc., is notused and the container is intact, the container may be retrieved andused with its integrity preserved.

Furthermore, supplying a pharmaceutical agent in a single-dose containerpermits accurate delivery of a unit dose. This is an advantage whichbecomes especially important when relatively small amounts of thepharmaceutical agent must be delivered, as in the case of certainhormones. Such uniformity is more difficult to achieve via a tabletingprocess where solids must be uniformly mixed and compressed, or viaincorporation of the total dose of active ingredient into a bulk liquidcarrier which then requires precise measurement of each dose prior toeach administration.

Single-dose cosmetics, nutritional supplements, or pharmaceuticals aretraditionally packaged in small bottles with a removable stopper, with aspray device, or in sachets with a tearable tab or with a line ofweakness for delivering these products. U.S. Pat. No. 6,315,480discloses a device for diffusing a fluid product dose contained in asealed reserve defined by an envelope made of a flexible and ductilematerial, such that a collapsing pressure applied on the reserve causesthe envelope to burst open releasing the product contained in thereserve. The envelope is locally provided with an area of reducedthickness forming a pre-opening, so as to cause the envelope to burstopen at the pre-opening, thereby channeling the product through thepre-opening in a predetermined direction. The flexible and ductilematerial may be plastic. The device is applicable for delivery of apharmaceutical, cosmetic, food, hygiene, perfume, or household-cleaningproducts. The area of reduced thickness may have perpendicular linesallowing the product to be sprayed out.

WO 2007/145535 discloses a sachet that can be opened by application of acompression force to form an opening in the package at a line ofweakness. The publication teaches that various mechanisms are known toaid in control of the rupturing and dispensing process and thattypically at least one web is made from a relatively stiff or semi-rigidmaterial which has a region that is weakened by a cut or a pattern ofcuts or other zones of weakness. The line of weakness may be produced bymaking a cut in the material to create a thinner portion of the materialat the line of weakness compared to adjacent portions of the material ofthe package.

U.S. Pat. No. 6,007,264 discloses a small sized shallow pouch-likecontainer for a dispensable ingredient that includes a pair of built-inoutwardly pivotable flaps positioned on opposite sides of thecontainer's outlet end to form a package applicator. Squeezing thecontainer's sides with the fingers expresses the stored ingredientthrough the outlet and onto the applicator flaps. Using the containerportion as a finger grip, the flaps may be moved about the desiredsurface, spreading the dispensed ingredient. In a preferred embodiment,the container and applicator combination is formed by a pair of flexiblefoil sheets of substantially identical structure that are superimposedover one another and partially connected together to define both thecontainer and the applicator. The container may be made from athermoplastic material and can be used for holding perfume and othercosmetics.

U.S. Pat. No. 5,270,054 discloses a capsule for storing a cosmeticcomposition. The capsule has a spheroidal body with a hollow chamberforming a major portion of the capsule, a tab connected with the majorportion by a neck section, which may be broken upon twisting to releasethe cosmetic composition from the hollow chamber. The opened capsule maybe gently squeezed to force the stored cosmetic composition out of thepunctured opening. The capsule may be a softgel capsule made fromgelatin selected from Type A, Type B or a combination thereof. Theamount of cosmetic composition held in the capsule ranges from about0.05 to about 5 grams, or from about 0.3 to about 2 grams.

U.S. Pat. No. 5,380,534 discloses a soft gelatin capsule with knurledsurfaces on the shell to enhance gripping and manipulation of thecapsule. Besides gelatin, the soft gelatin capsule also comprises astarch or starch derivative, as well as a thickener (such ascarrageenans). In one embodiment, the soft gelatin capsule shellcomprises acylated gelatin, high amylose starch, and glycerol. The softgelatin capsule comprises a removable tab integrally formed with themain portion of the capsule to seal the capsule. The neck portionconnecting the removable tab and the main portion of the capsule can beeasily broken by twisting off the tab. The contents of the capsule maythen be dispensed by squeezing the capsule.

U.S. Pat. No. 5,063,057 discloses a capsule for packaging a cosmeticproduct. The capsule has a round body with a hollow chamber and a tabconnected with the hollow chamber by a neck section. The tab may beremoved by twisting and breaking the neck section to allow release ofthe cosmetic product. The capsule may be made from a soft gelatin gel.The amount of cosmetic product held in the capsule ranges from about0.05 to about 5 grams, or from about 0.3 to about 2 grams.

U.S. Pat. No. 6,280,767 discloses a soft gelatin capsule of thetorsional opening type made of gelatin, one or more plasticizers, and awater-insoluble cellulose. The soft gelatin capsule has an elongatedbody comprising a narrow rupture portion. The soft gelatin capsule canbe twisted open with the fingers at the rupture portion by applicationof a torsional force thereto.

WO 1994/014356 discloses a sample container comprising a centralcosmetic-containing portion substantially surrounded by a peripheralportion with thickened edges. The central portion is preferably made ofa soft gelatin, while the thickened edges may be made of a solidgelatin. In a preferred embodiment, the container is made of softgelatin. A narrowed neck portion connects the centralcosmetic-containing portion to a tab, removal of which provides accessto the cosmetic product in the central cosmetic-containing portion. Thecentral cosmetic-containing portion is preferably cylindrical or anoblong cylindrical shape. According to WO 1994/014356, the cosmetic inthe container may be perfumes, lotions, or creams.

These single-dose containers often need to be opened by tearing ortwisting using one's hands. Such containers may be difficult to handlefor some people in that they require two hands to open. In addition,many such containers that provide sprayable delivery are notbiodegradable while many containers that are biodegradable do notprovide sprayable delivery, which is advantageous for many applications.

Thus, one objective of the present invention is to eliminate theaforementioned drawbacks of present single dose containers, and toprovide a container for delivering a single-dose of a fluid product. Invarious aspects of the invention a container is provided that is simpleto use, inexpensive to manufacture, completely biodegradable, effectivein operation, compact, and lightweight

Also, in some embodiments, the container of the present inventionprovides the ability to spray the product out of the container to permitapplication of the product by spraying over an area. This feature isparticularly advantageous for dispensing of cosmetics, cleaning productsor other products that are intended to be spread over an area for use.More particularly, the single-dose container of the present inventionmay comprise an area of reduced thickness, which bursts when thecontainer is compressed. The content within the container may thus besprayed or squeezed out to an intended location.

SUMMARY OF THE INVENTION

In one aspect, the present invention provides a softgel capsule packagefor delivering a single-dose product. The softgel capsule packageincludes a softgel capsule shell (5) formed from at least one gellingagent selected from a protein and a polysaccharide. The softgel capsuleshell (5) includes at least one area having a first shell thickness, andone or more areas of reduced shell thickness configured topreferentially rupture by exertion of a compression force on the softgelcapsule shell (5) to provide an opening in the capsule shell (5) throughwhich a fill contained in the package (100) can be dispensed.

In another aspect, the present invention provides a method formanufacturing the softgel capsule package. The method includes providinga fill composition between two pieces of softgel material, fusing thetwo pieces of softgel material to form a softgel capsule encapsulatingthe fill composition; and creating at least one area of reducedthickness (3) on a capsule shell (5) of the softgel capsule prior to orduring said fusing step.

In one aspect, the invention provides a softgel capsule package that canbe opened by squeezing and the contents of the package can also bedispensed by squeezing.

In a further aspect, the invention provides a softgel capsule packagethat can be opened by squeezing and the contents of the package can bedispensed in the form of a spray by exertion of a compressive force onthe package.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic representation of a softgel capsule according toone embodiment of the present invention.

FIG. 2 is a schematic representation of a softgel capsule with aprotrusion, according to one embodiment of the present invention.

FIGS. 3A-3B show different embodiments of areas of reduced thickness onsoftgel capsules as viewed from the right side of FIG. 1.

FIG. 3C shows an area of reduced thickness on a softgel capsule with thearea of reduced thickness circumscribing a portion of the softgelcapsule.

FIG. 3D shows an embodiment of softgel capsule that has two protrusionsand wherein the area of reduced thickness is located between the twoprotrusions (cat ear shape).

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT(S)

For illustrative purposes, the principles of the present invention aredescribed by referencing various exemplary embodiments. Although certainembodiments of the invention are specifically described herein, one ofordinary skill in the art will readily recognize that the sameprinciples are equally applicable to, and can be employed in, othersystems and methods. Before explaining the disclosed embodiments of thepresent invention in detail, it is to be understood that the inventionis not limited in its application to the details of any particularembodiment shown. Additionally, the terminology used herein is for thepurpose of description and not for limitation. Furthermore, althoughcertain methods are described with reference to steps that are presentedherein in a certain order, in many instances, these steps can beperformed in any order as may be appreciated by one skilled in the art;the novel method is therefore not limited to the particular arrangementof steps disclosed herein.

It must be noted that as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include plural references unless thecontext clearly dictates otherwise. Furthermore, the terms “a” (or“an”), “one or more”, and “at least one” can be used interchangeablyherein. The terms “comprising”, “including”, “having” and “constructedfrom” can also be used interchangeably.

In one aspect, the present invention provides a package 100 fordelivering a single-dose product as shown in FIG. 1. The package 100includes a capsule shell 5. The capsule shell 5 includes one or moreareas of reduced thickness 3 that enable opening of the package 100 bycompressing the package 100 to cause rupture of the capsule shell 5 atthe one or more areas of reduced thickness 3. A fill contained in thepackage 100 can be reliably dispensed from the package 100 via the oneor more ruptured areas of reduced thickness 3 by being sprayed orsqueezed out of the capsule shell 5 to an intended dispensing location.

The capsule shell 5 of the package 100 is impermeable to the filltherein, but could be permeable to other solvents, such as water. Thepackage 100 provides a single-dose product and thus is small in size.The volume of the package 100 may be from about 0.05 to about 5 ml, orfrom about 0.1 to about 3 ml, or about 0.2 to about 2 ml, or about 0.25to about 1 ml.

The package 100 may have a variety of shapes including common shapessuch as spheres, oblong shapes, elongated tubes, disks, squares,rectangles, cylindrical shapes, ellipsoidal shapes, cat ear shapes orother geometrical shapes. The package 100 may also have shapes that arecustomized for a specific product or vender, such as sports mascots,logos, sporting goods, and likenesses of animals and humans, or portionsthereof.

The one or more areas of reduced thickness 3 may be located anywhere onthe capsule shell 5. In some embodiments, the area of reduced thicknesswill be offset from the center of the capsule shell 5 to provide a largeportion of the capsule shell 5 that can be compressed to rupture thearea of reduced thickness 3. In some embodiments, the area of reducedthickness 3 is located at an end or a corner of the package 100 wherethe package 100 has an end or a corner (such as rectangular shape orspheroidal shape, FIG. 1). In some embodiments, two areas of reducedthickness 3, or three areas of reduced thickness 3, or four or moreareas of reduced thickness, may be provided as a cluster on the capsuleshell 5. The plurality of areas of reduced thickness 3 may be used toprovide a spray of a plurality of streams of the fill when dispensedfrom the package 100 that might be useful when spreading the fill overan area is desired.

In a preferred shape, the area of reduced thickness 3 is a decreasedland or surface area bounded by two protrusions 2 such as in the cat earshape shown in FIG. 3D. The land or surface area is decreased in thesense that the protrusions 2 define borders of the land or surface areawithin which the area of reduced thickness 3 may be located, therebydecreasing the potential size of an opening created by exerting pressureon the area of reduced thickness 3, relative to a similar packagewithout the protrusions 2. These two protrusions 2 stabilize the fillmaterial in the capsule and create a back pressure directly on the areaof reduced thickness 3. The pressure may rupture the area of reducedthickness 3 to express the fill material. The area of reduced thickness3 also provides a specific start point for the expression, as well asfanning the fill material between the two protrusions 2.

The cat ear shape package 100 of FIG. 3D may include an air hole locatedin a central area of the package 100. Also, the walls of the package maybe shaped, as shown in FIG. 3D, to help direct compressive force appliedto the package 100 to the area of reduced thickness 3 to facilitate bothopening the package 100 and dispensing of the contents of the package100, particularly for spray dispensing.

The area of reduced thickness 3 may be a dot, a line, or multiple linesthat are parallel or intersecting as shown in FIGS. 3A-3D. In someembodiments, the area of reduced thickness 3 may have a shape such asfantasy shapes, animals, flowers, a sun, other natural patterns orportions thereof, preferably located in a decreased land area betweentwo protrusions 2, where the two protrusions 2 have the shape of, forexample, ears, tails, hands, noses and the like. The area of reducedthickness may be of different lengths or widths in order to customizethe rate or pattern of dispensing of the fill from the package 100.

The area of reduced thickness 3 is more fragile than the remainder ofthe capsule shell 5 and thus will be preferentially ruptured when asufficient compression force is applied to the package 100. The pressuremay be applied via hand or finger pressure such as by squeezing thepackage. The pressure may also be applied by a device designed for usewith the package of the invention such as a home deodorizer or similarsmall appliances provided with structure that can exert a compressiveforce on the package 100. The appliances may be able to squeeze thepackage 100 following an established rhythm/path to provide the desireddispensing from package 100.

The ruptured area of reduced thickness 3 becomes an ejection orifice forthe fill of the package 100 which provides a channel through capsuleshell 5 for dispensing the fill. The fill may be dispensed as a sprayand/or by squeezing the fill from the package 100 in a predetermineddirection. The fill may be sprayed or squeezed onto the intendedlocation of use.

In one embodiment, the package 100 may be in the form of an oblong/tearshape. In this embodiment, the application of pressure on the sideswhere the sealing line resides provides an excellent spray effect. Inaddition, this embodiment is easy to use and facilitates control of thespray effect. The extended radius on each side of the break point causesthe fill material to find the center location during application ofpressure. The area of reduced wall thickness 3 enhances the break andallows fill material to express at the center point. The area of reducedthickness 3 may be sized to provide a desired dispensing such as a finespray.

In some embodiments, the package 100 may have a main body 1 and aprotrusion 2 as shown in FIG. 2. The main body 1 may have any shape suchas a shape of a sphere, a spheroidal shape, an ellipsoidal shape, arectangular shape, a cylindrical shape or a cubic shape. The protrusion2 extends, preferably radially outwardly, from the main body 1. Theprotrusion 2 may be any shape such as a bulge, a cylindrical protrusion,a finger-like shape, or in the form of a likeness of an ear, tail, hand,nose, and the like. In some embodiments, the protrusion 2 may extendless than about 0.5 mm, or less about 0.4 mm, or less than about 0.3 mm,or less than about 0.2 mm from the main body 1.

The area of reduced thickness 3 may be located on the protrusion 2. Theuser can compress the main body 1 of package 100 in order to rupture thearea of reduced thickness 3 on the protrusion 2. Placing the area ofreduced thickness 3 on the protrusion 2, at the tip or in a decreasedland area of protrusion 2, may offer convenience for dispensing the fillto certain locations such as inside of the ears, nose, or mouth. Theprotrusions help direct the fill to flow to the location of the area ofreduced thickness 3 in order to facilitate dispensing and, in someembodiments, to help focus the exertion of pressure on the area ofreduced thickness 3 to facilitate opening the package 100.

In some embodiments, a plurality of protrusions 2 may be present on thepackage 100 each with an area of reduced thickness 3. In someembodiments, the package 100 has two protrusions 2 where the area ofreduced thickness 3 is located in a decreased land area between the twoprotrusions 2. The plurality of protrusions 2 may form a cluster on thepackage 100. In some embodiments, plurality of protrusions 2 withplurality of areas of reduced thickness 3 may provide a plurality ofdispensing streams when it is desirable to spray the fill out of thepackage 100 over a relatively large area, for example for perfumes ordeodorants.

Optionally, at least a portion of the surface of the capsule shell 5 maybe textured by providing textured areas 4 as shown FIG. 2. The texturingmay be provided by, for example, a raised pattern on the surface of thepackage 100 such as ridges, stripes, bars, bands, streaks, strips,spots, striations, ribs, and combinations thereof, and combinationsthereof. This texturing can be applied to capsule shells that comprisegelatin. The texturing may also be provided by one or more indentationsin the surface of the package 100 of any suitable size or shape thoughcare must be taken not to create an area of weakness that could ruptureduring compression. A user may hold and compress the package 100 at thetextured areas 4 for ease of handling and/or to improve grip on thepackage 100 during compression of the package 100 for dispensing. Thetexture 4 is preferably imparted to the package 100 during themanufacturing process by, for example, use of a die that providestexture to the film used to form the capsule shell 5.

The softgel capsule shell 5 of the package 100 is formed from at leastone gelling agent. In some embodiments, the softgel capsule shell 5 maybe formed from a combination of two gelling agents. The gelling agentsof the present invention may be selected from protein-based gellingagents and polysaccharide-based gelling agents.

Protein-Based Gelling Agents

The protein-based gelling agent may be selected from collagen, eggwhites, gelatin, or milk-based proteins. “Collagen” refers to a proteinof connective tissue in animals. “Gelatin” refers to a translucent,colorless, odorless, brittle, nearly tasteless solid protein substance,derived from the collagen by partial hydrolysis. Generally, gelatin isclassified into alkaline gelatin, acidic gelatin, or enzymatic gelatin.Alkaline gelatin is obtained from the treatment of collagen with a basesuch as calcium hydroxide. Acidic gelatin is obtained from the treatmentof collagen with an acid such as hydrochloric acid. Enzymatic gelatin isgenerated from treatment of collagen with a hydrolase. Gelatin iscommonly used as a gelling agent in food, pharmaceuticals, photography,and cosmetic manufacturing. In the context of the present invention,“gelatin” also includes substantially equivalent substances such assynthetic analogues of natural gelatin.

Polysaccharide-Based Gelling Agents

The gelling agent of the present invention may also bepolysaccharide-based. The polysaccharide-based gelling agents arecommonly derived from a plant source, such as starch or cellulose. Thepolysaccharide-based gelling agent may be selected from cellulose orcellulose derivatives, such as microcrystalline cellulose, sodiumcarboxymethyl cellulose, methylcellulose, ethyl cellulose, hydroxyethylcellulose, hydroxypropyl cellulose, and hydroxypropyl methylcellulose,starch and starch derivatives, pectin, gum, dextrins, alginates andcarrageenans. Exemplary starches include arracacha starch, arrowrootstarch, banana starch, barley starch, breadfruit starch, buckwheatstarch, canna starch, cassava starch, colacasia starch, corn starch,katakuri starch, kudzu starch, malanga starch, millet starch, oatstarch, oca starch, pea starch, polynesian arrowroot starch, potatostarch, rice starch, rye starch, sago starch, sorghum starch, sweetpotato starch, taro starch, water chestnut starch, wheat starch, yamstarch, and mixtures thereof.

The starch of the present invention may be a modified starch. The term“modified starch” refers to derivatives prepared by chemical treatmentof starches, for example, acid treatment starches, enzyme treatmentstarches, oxidized starches, cross-bonding starches, and other starchderivatives. It is preferred that the modified starches be derivatizedwhere their side chains are modified with hydrophilic or hydrophobicgroups to thereby form a more complicated structure with a strongerinteraction between side chains comparing with unmodified starches.Exemplary modified starch ethers and esters include carboxymethylatedstarch, hydroxypropylated starch, and hydroxypropylated carboxymethylcrosslinked starch.

“Modified starch ester” refers to a starch in which one or more of thehydroxyl groups have been reacted to form ester groups. The reactionusually involves a reaction to replace the hydrogen of the OH group onthe starch with a —O—(C═O)—CH₃ or —O—(C═O)—R group (where R is analiphatic group).

“Modified starch ether” refers to a starch in which one or more of thehydrogens on the starch has been replaced by the carbon of an organicgroups. For example methylation of a starch replaces the OH group withan OCH₃ group.

Gum

The polysaccharide-based gelling agent of the present invention may alsobe a gum. Exemplary gums include acacia gum, agar, carrageenans, cassiagum, cellulose gum, furcellaran, gellan gum, guar gum, gum ghatti,karaya gum, larch gum, locust bean gum, pectin, plantago, tara gum,tragacanth, xanthan gum, or a combination thereof.

“Gum” refers to polysaccharides of natural origin, capable of causing alarge viscosity increase in solution, even at small concentrations. Theyare used as thickening agents, gelling agents, emulsifiers, andstabilizers. Most often, these gums are found in the woody elements ofplants or in seed coatings.

Pectin

The polysaccharide-based gelling agent of the present invention may bepectin. “Pectin” refers to the complex set of polysaccharides that arepresent in most primary cell walls and particularly abundant in thenon-woody parts of terrestrial plants. The characteristic structure ofpectin is a linear chain of α-(1-4)-linked D-galacturonic acid thatforms the pectin-backbone, a homogalacturonan. Into this backbone, thereare regions where galacturonic acid is replaced by (1-2)-linkedL-rhamnose. From the rhamnose residues, side chains of various neutralsugars branch off.

The pectin of this invention include not only purified or isolatedpectates, but also crude natural pectin sources, such as apple, citrusor sugar beet residues which have been subjected, when necessary, toesterification or de-esterification, e.g., by alkali or enzymes.Preferably, the pectins used in this invention are derived from citrusfruits such as lime, lemon, grapefruit, and orange.

Dextrin

The polysaccharide-based gelling agent may be dextrin. “Dextrin” refersto a group of low-molecular-weight carbohydrates produced by thehydrolysis of starch or glycogen. Dextrin is a mixture of polymers ofD-glucose units linked by α-(1→4) or α-(1→6) glycosidic bonds.

Alginates

The polysaccharide-based gelling agent of the present invention may bealginate. “Alginate” refers to an anionic polysaccharide distributedwidely in the cell walls of brown algae, where through binding withwater, it forms a viscous gum. Alginate is a linear copolymer withhomopolymeric blocks of (1-4)-linked β-D-mannuronate (M) and its C-5epimer α-L-guluronate (G) residues, respectively, covalently linktogether in different sequences or blocks. Its color ranges from whiteto yellowish-brown. It is sold in filamentous, granular, or powderedforms.

Carrageenans

The polysaccharide-based gelling agent of the present invention may be acarrageenan. In some embodiments, carrageenan may provide particularadvantages. “Carrageenan” refers to a family of polysaccharide gumsextracted from red seaweed. They consist of linear sulfated highmolecular weight polysaccharides made up of repeating galactose unitsand 3, 6 anhydrogalactose (3,6-AG), both sulfated and nonsulfated. Theunits are joined by alternating alpha 1-3 and beta 1-4 glycosidiclinkages.

In some exemplary embodiments, the capsule shell 5 of the package 100comprises both a modified starch and iota-carrageenan. In oneembodiment, the weight ratio of the modified starch to theiota-carrageenan is at least about 1.5:1, with a preferred range beingabout 1.5:1 to about 4:1, or more preferably from about 2:1 to about3:1. A gel forming composition with the above weight ratio is capable offusion, under pressure, in the range of about 207 kPa to about 2070 kPa(about 30 to about 300 psi) and at temperatures in the range of fromabout 25 to about 80° C. In one embodiment, the capsule shell 5,according to the present invention, has a melting temperature of fromabout 2 to about 25° C., more preferably from about 3 to about 15 ° C.and most preferably about 4 to about 9° C. above its fusion temperature.

The iota-carrageenans may be preferably conformed to the specificationlaid down by the USA and European regulatory authorities. Theiota-carrageenan is not degraded and should conform to minimum viscositystandards, which correspond to a molecular weight of about 100K Daltons.Standardized iota-carrageenans are preferred. A particular preferredstandardized iota-carrageenan is commercially available from the FMCCorporation of Princeton, N. J., known as VISCARIN® SD389, standardizedwith 15% by weight dextrose. Other useful iota-carrageenans include anon-standardized iota-carrageenan from SKW BioSystems of Baupt, Franceknown as XPU-HGI and a non-standardized iota-carrageenan from FMC.

The iota-carrageenan in these exemplary embodiments is used in an amountthat, in combination with the modified starch, effectively causes thegel forming compositions to have the required gelatin-like functionalproperties. As those skilled in the art will appreciate, the gel haswhat is known as a wet shell composition and a dry shell composition.The dry shell composition results from the evaporation or removal ofwater from the wet shell composition during the manufacturing processfor making the softgel capsule. The dry shell composition may stillcontain some water. Preferred amounts of iota-carrageenan range fromabout 6-12% by weight of the wet shell composition. More preferredamounts of iota-carrageenan range from about 7-12% by weight of the wetshell composition. Particularly preferred compositions contain about9-11 weight % of iota-carrageenan, based on the weight of the wet shellcomposition. Even more preferred compositions contain about 10 weight %of iota-carrageenan by weight of the wet shell composition.

In some other exemplary embodiments, the capsule shell 5 is formed fromonly one gelling agent, which is gelatin. Preferably, the gelatin ismammalian gelatin. The capsule shell 5 typically contains between about25-45% by weight of gelatin. Such gelatin-based gel is strong enough tosurvive manipulation in the encapsulation machine, provide good sealingproperties at temperatures below the melting point of the film, and havesufficient elasticity to allow for the formation of the package 100.

The capsule shell 5 of the package 100 may further comprise at least oneoptional component selected from a plasticizer, a preservative, aflavoring agent, an opacifying agent, a buffer, an embrittlementinhibiting agent, a colorant, a disintegrant, a perfume, a flavoring, ashell texturing ingredient and/or pearlescent and/or glittering pigment,and water.

The plasticizers include glycerol, polyglycerol, glycerin, propyleneglycol, polyethylene glycol, xylitol, sorbitol, non-crystalizingsolutions of sorbitol, glucose, fructrose, and glucose syrups. Theseplasticizers may be used alone or in combination with each other. In acombination of plasticizers including glycerol, the glycerol typicallycomprises at least 30% by weight of the combination, normally in therange of about 30-70% by weight. One alternative combination isANIDRISORB (a proprietary mixture of Sorbitol, Sorbitans, Maltitol, andMannitol, available from Roquette Freres). Other plasticizers includesaccharides and polysaccharides. The saccharides and polysaccharidessuitable for use as a plasticizer herein may be produced by hydrolysisand/or hydrogenation of a simple or complex polysaccharides.

Where plasticizers are employed, they can be used in amounts of up toabout 60% by weight of the dry shell composition or up to about 30% byweight of the wet shell composition used to make the capsule. Morepreferred compositions contain from about 10% to about 25% by weight,based on the weight of the wet shell composition and from about 30% toabout 50% by weight of the dry shell composition.

Optionally, the capsule shell 5 may contain a preservative.Preservatives may be antimicrobial preservatives, which inhibit thegrowth of microbes, or they can be antioxidants such as oxygenabsorbers, which inhibit the oxidation of fill within the package 100.Common antimicrobial preservatives include sorbic acid and its salts,benzoic acid and its salts, calcium propionate, sodium nitrite, sulfites(sulfur dioxide, sodium bisulfite, potassium hydrogen sulfite, etc.),and disodium ethylenediaminetetraacetic acid (EDTA). Antioxidantsinclude butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT),tert -butylhydroquinone (TBHQ) and propyl gallate. Other preservativesinclude ethanol and methylchloroisothiazolinone.

Without preservatives, the wet capsule composition may be spoiled bymicrobial growth in a day or two. On a commercial scale, however,preservatives may not be needed because the wet ribbon would be quicklyprocessed through the encapsulation machines and then the dryers. Thedried capsule shell 5 does not support microbial growth.

In some embodiments, the capsule shell 5 may lose ductility duringstorage or shelf life, making it brittle. An embrittlement inhibitingagent may be added, which may be a mixture of sorbitol and one or moresorbitans. See U.S. Pat. No. 4,780,316, which is incorporated herein byreference.

In some embodiments, a buffer system may be used in the composition forforming capsule shell 5. Any known buffer can be used, with phosphatebuffers being preferred. Controlling the pH of the composition may behighly important in some embodiments as carrageenans are rapidly brokendown in conditions of acidity.

The fill materials for the soft package 100 may be any of a wide varietyof materials suitable for encapsulation, including oils, hydrophilicliquids, and emulsions, silicone based serums. The fill material may beliquid, semi-solid, or suspension. The active components that may becontained within the oils and emulsions are hydrophobic and hydrophilicactives. Those skilled in the art are familiar with and will recognizesuitable fill materials.

The package can be used for delivery of a multitude of products as fillmaterials from the package. Such products include, but are not limitedto, cosmetics such as perfumes and serums, foods, hygiene products,medical devices, nutritional supplements, household products such ascleaning products, deodorizing products, polishing products, flavorings,veterinary medicines or other animal health products, andpharmaceuticals. From a regulatory perspective, the packages 100 aremedical devices, which are regulated as a specific class of products.

The package 100 may be produced by fusing two different pieces of gel toform the capsule shell 5. The fusion of the two pieces of gel isperformed by subjecting the gel to sufficient pressure and/or elevatedtemperature. The temperature at which fusion of two opposing filmsoccurs should be below the melting point of the film, i.e., the fusionor sealing temperature is less than the melting point of the filmcomposition.

A traditional technology for manufacturing the package 100 is the rotarydie process for producing soft capsules in a continuous softgel capsulemanufacturing process. Rotary die manufacture of softgel capsules isdisclosed in detail in Ebert, W. R., “Soft elastic gelatin capsules: aunique dosage form”, Pharmaceutical Tech., October 1977; Stanley, J. P.,“Soft Gelatin Capsules”, in The Theory and Practice of IndustrialPharmacy (Lachman, Lieberman and Kanig, Editors), 3rd Edition, publishedby Lea & Febiger, U.S. Pat. Nos. 1,970,396; 2,288,327; and 2,318,718. Agood description of gelatin encapsulation techniques can also be foundin WO 98/42294.

The packages 100 made by using the rotary die process typically havecapsule shell thicknesses varying from about 0.024 cm to about 0.1778cm, preferably from about 0.0350 cm to about 0.0508 cm and morepreferably from about 0.0406 cm to about 0.0508 cm. The areas of reducedthickness 3 of capsule shell 5 will typically be from about 30% to about70% thinner than other portions of capsule shell 5, and more preferablyfrom about 40% to about 50% thinner than other portions of capsule shell5.

In the method of the present invention, the areas of reduced thickness 3may be formed by adaptation of one or more of the die used to form thecapsule shell 5 to form an area of reduced thickness 3. Thus, theflexible ribbon of gel material fed to the die may be modified by thedie to provide one or more areas of reduced thickness 3 during themanufacturing process. In this manner, the softgel capsules of theinvention may be manufactured in a continuous manner while providing thedesired one or more areas of reduced thickness 3 to the capsule shell 5to permit opening of the package 100 by application of a compressiveforce as described above.

Other suitable methods of forming areas of reduced thickness 3 may alsobe employed. For example, the flexible ribbon of capsule shell materialfed to the rotary die may be provided with one or more areas of reducedthickness in the ribbon prior to feeding the ribbon to the rotary dieused to form the capsule shell 5. Alternatively, capsule shell 5 couldbe scored after manufacture of capsule shell 5 to provide an area ofreduced thickness 3. In a preferred embodiment, the area of reducedthickness 3 is located in a decreased land area between two protrusions2 forming the cat ear shape of FIG. 3D.

The invention also includes a method for manufacturing the package(100). In the method, a fill composition is provided between two piecesof softgel material. The two pieces of softgel material are then fusedtogether using known techniques to form a softgel capsule encapsulatingthe fill composition. Finally, at least one area of reduced thickness(3) is created on a capsule shell (5) of the softgel capsule prior to orduring said fusing step. The area of reduced thickness is maintainedthroughout the drying and hardening of the capsule.

The packages 100 may be stored and dried in a special cabinet with fansthat produce a constant air flow in the cabinet. The drying process istypically performed for a period from one to eight hours, preferablyfrom two to about six hours, more preferably from three to about fourhours. During this drying period, the packages 100 reach a hardness ofsqueezable packages. The package's hardness is in a range of from 0.5Nto about 3N, preferably from 1N to about 2.5N, and more preferably from1.5N to about 2N.

It is to be understood, however, that even though numerouscharacteristics and advantages of the present invention have been setforth in the foregoing description, together with details of thestructure and function of the invention, the disclosure is illustrativeonly, and changes may be made in detail, especially in matters of shape,size and arrangement of parts within the principles of the invention tothe full extent indicated by the broad general meanings of the terms inwhich the appended claims are expressed.

What is claimed:
 1. A softgel capsule package for delivering asingle-dose product, comprising: a softgel capsule shell formed from atleast one gelling agent selected from a protein and a polysaccharide,the softgel capsule shell including at least one area having a firstshell thickness, and one or more areas of reduced shell thicknessconfigured to preferentially rupture by exertion of a compression forceon the softgel capsule shell to provide an opening in the capsule shellthrough which a fill contained in the package can be dispensed.
 2. Thepackage of claim 1, wherein the softgel capsule shell is impermeable toa fill material contained in the package.
 3. The package of claim 1,wherein the softgel capsule package has an internal volume of from about0.05 to about 5 ml, or from about 0.1 to about 3 ml, or about 0.2 toabout 2 ml, or about 0.25 to about 1 ml.
 4. The package of claim 1,wherein the softgel capsule shell has a shape selected from spherical,oblong, tubular, cylindrical, square, rectangular, disk-shaped, cat earand ellipsoidal.
 5. The package of claim 1, wherein the one or moreareas of reduced thickness are circular, or linear.
 6. The package ofclaim 1, wherein the softgel capsule shell defines a main body and atleast one protrusion.
 7. The package of claim 6, wherein the one or moreareas of reduced thickness are located on the protrusion.
 8. The packageof claim 6, comprising two protrusions and the one or more areas ofreduced thickness are located in the decreased land area between the twoprotrusions.
 9. The package of claim 7, wherein the protrusion extendsless than about 0.5 mm, or less about 0.4 mm, or less than about 0.3 mm,or less than about 0.2 mm from the main body.
 10. The package of claim1, wherein the surface of the softgel capsule shell further comprises atextured area.
 11. The package of claim 10, wherein the textured area isformed by one or more structures selected from ridges, stripes, bars,bands, streaks, strips, spots, striations, ribs, and combinationsthereof.
 12. The package of claim 1, wherein at least one gelling agentis a protein-based gelling agent.
 13. The package of claim 12, whereinthe protein-based gelling agent is selected from the group consisting ofcollagen, gelatin, egg whites, and milk-based proteins.
 14. The packageof claim 1, wherein at least one gelling agent is a polysaccharide-basedgelling agent.
 15. The package of claim 14, wherein thepolysaccharide-based gelling agent is selected from the group consistingof cellulose-based materials, starches, modified starches, pectins,gums, dextrins, alginates, carrageenans and mixtures thereof.
 16. Thepackage of claim 1, wherein the softgel capsule is formed from at leasttwo gelling agents.
 17. The package of claim 16, where the gellingagents comprise modified starch and iota-carrageenan.
 18. The package ofclaim 1, where at least one gelling agent is gelatin.
 19. The package ofclaim 18, where the gelatin has an amount of about 25% to about 45% byweight of the sofgel capsule shell.
 20. The capsule of claim 1, whereinthe capsule further comprising one or more components selected from thegroup consisting of a plasticizer, a preservative, a flavoring agent, anopacifying agent, a buffer, an embrittlement inhibiting agent, acolorant, a disintegrant, a perfume, a flavoring, a shell texturingingredient, a pearlescent, a glittering pigment, and water.
 21. Thecapsule of claim 17, wherein the capsule further comprises a componentselected from the group consisting of a plasticizer, a preservative, aflavoring agent, an opacifying agent, a buffer, an embrittlementinhibiting agent, a colorant, a disintegrant, a perfume, a flavoring, ashell texturing ingredient, a pearlescent, a glittering pigment andwater.
 22. The package of claim 1, where the capsule has a firstthickness from about 0.024 cm to about 0.1778 cm and a second thicknessin the area of reduced thickness that is from about 30% to about 70%, orfrom about 40% to about 50% thinner than the first thickness.
 23. Amethod for manufacturing the package of claim 1, comprising steps of:providing a fill composition between two pieces of softgel material,fusing the two pieces of softgel material to form a softgel capsuleencapsulating the fill composition; and creating at least one area ofreduced thickness on a capsule shell of the softgel capsule prior to orduring said fusing step.